[Federal Register Volume 80, Number 89 (Friday, May 8, 2015)]
[Notices]
[Pages 26590-26591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11075]


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REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION


Request for Steering Committee Nominations

ACTION: Request for nominations to the Steering Committee for the 
Foundation's Innovation in Medical Evidence Development and 
Surveillance (IMEDS) program.

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SUMMARY: The Reagan-Udall Foundation for the Food and Drug 
Administration (FDA), which was created by Title VI of the Food and 
Drug Amendments of 2007, is requesting nominations for its Innovation 
in Medical Evidence Development and Surveillance (IMEDS) Steering 
Committee. The IMEDS Steering Committee will provide oversight and 
guidance of the IMEDS Program, and will report to the Reagan-Udall 
Foundation for the FDA's Board of Directors. Instructions on making 
nominations are listed in the ``Background'' section.

DATES: All nominations must be submitted to the Reagan-Udall Foundation 
for the FDA by May 24, 2015. IMEDS Steering Committee members will be 
selected by the Reagan-Udall Foundation for the FDA's Board of 
Directors by July 2015; those selected will be notified by July 30, 
2015 regarding the Board's decision.
    Location: The Reagan-Udall Foundation for the FDA is located at 
1025 Connecticut Ave. NW., Suite 1000, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: Nicole Spear, Reagan-Udall Foundation 
for the FDA, 202-828-1210. Nominations should be sent to 
[email protected]. Email subject line: SC Nomination.

SUPPLEMENTARY INFORMATION:

I. Background

    The Reagan-Udall Foundation for the FDA (the Foundation) is an 
independent 501(c)(3) not-for-profit, organization created by Congress 
to advance the mission of FDA to modernize medical, veterinary, food, 
food ingredient, and cosmetic product development; accelerate 
innovation, and enhance product safety. With the ultimate goal of 
improving public health, the Foundation provides a unique opportunity 
for different sectors (FDA, patient groups, academia, other government 
entities, and industry) to work together in a transparent way to create 
exciting new research projects to advance regulatory science.
    The Foundation acts as a neutral third party to establish novel, 
scientific collaborations. Much like any other independently developed 
information, FDA evaluates the scientific information from these 
collaborations to determine how Reagan-Udall Foundation projects can 
help the agency to fulfill its mission.
    The Innovation in Medical Evidence Development and Surveillance 
(IMEDS) program is offered by the Foundation. IMEDS is a public-private 
partnership created to build upon the significant progress made on 
research methodology by the Sentinel Initiative and the

[[Page 26591]]

Observational Medical Outcomes Partnership (OMOP).
    IMEDS's primary objective is to advance the science and tools 
necessary to support post-market evidence generation on regulated 
products, including safety surveillance and evaluations, and to 
facilitate utilization of a robust electronic healthcare data platform 
for generating better evidence on regulated products in the post-market 
settings. To accomplish this objective, the IMEDS program includes 
three projects:
    1. IMEDS-Methods: Supports the development of a methods research 
agenda and coordination of methods research in support of using 
electronic health data for safety surveillance conducted by FDA as well 
as the broader community of researchers.
    2. IMEDS-Education: Offers educational opportunities in areas 
related to medical product safety surveillance, and methods research 
and application for scientific professionals.
    3. IMEDS-Evaluation: Applies Methods and Education lessons learned 
for medical product assessments to facilitate leveraging Sentinel tools 
and capabilities toward a national resource for evidence generation.
    The IMEDS Steering Committee will have oversight of all IMEDS 
projects.

II. IMEDS Steering Committee Positions and Selection Criteria

    RUF is seeking nominations for two (2) voting members of the IMEDS 
Steering Committee listed below.
    1. At Large (excluding Pharmaceutical representative): 1 member.
    2. Provider (i.e., Clinician): 1 member.
    The following criteria will be used to evaluate nominees for the 
IMEDS Steering Committee.
    1. Required Criteria for Each of 2 Positions
    a. Currently employed by/volunteering for stakeholder field (e.g., 
academia, patient advocate, provider etc.) with several years of 
relevant experience.
    b. Leading expert in their relevant field (based on position/title, 
publications, or other experience).
    2. Criteria across Steering Committee (It is not a requirement that 
all nominees meet all of these criteria, but collectively, the Steering 
Committee members should meet them.)
    a. Ability to complete Steering Committee responsibilities (which 
can be accessed via the IMEDS Web site: http://imeds.reaganudall.org/governance.)
    b. Prior experience serving on a related or similar governance 
body.
    c. Understanding of post-market surveillance landscape and impact 
upon stakeholder group represented by Steering Committee seat, or 
understanding of issues around use of electronic health data for 
observational purposes.
    d. Individuals both with and without past experience in Mini-
Sentinel, OMOP, and similar research/regulatory science initiatives to 
ensure a diversity of perspectives.
    e. Individuals from both U.S.- and international-based 
institutions.

III. Terms of Service

     The IMEDS Steering Committee meets in-person at least 
twice per year, with bimonthly teleconferences in between meetings (or 
monthly teleconferences as deemed necessary by the Chair).
     Members serve two-year terms, and a maximum of two terms 
(based on IMEDS fiscal calendar).
     Members do not receive compensation from RUF.
     Members can be reimbursed by RUF for actual and reasonable 
expenses incurred in support of IMEDS in accordance with applicable law 
and their specific institutional policies.
     Members are subject to the IMEDS Conflict of Interest 
policies.

IV. Nomination Instructions

     To apply, please submit the nominee's CV and the 
nomination form that can be found on the IMEDS Web site: 
imeds.reaganudall.org, to [email protected] with ``SC Nomination'' 
in the subject line.
     Individuals may be nominated for one or more of the 2 
voting positions, and those making nominations should specify for which 
of the 2 voting positions the nominee is being nominated.
     Individuals may nominate themselves.

    Dated: May 4, 2015.
Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation for the FDA.
[FR Doc. 2015-11075 Filed 5-7-15; 8:45 am]
 BILLING CODE 4164-04-P